9 results
·
19ms
·
Sources: EU EUDAMED, US FDA
BRAINLAB MICRO MULTI-LEAF COLLIMATOR
FDA 510(k)
FDA Class 2
·Radiology
artegral
FDA UDI
Merz Dental GmbH·D7091970586·anteriors; shade A2 light; mould BS
Strep B Carrot Broth One-Step
FDA 510(k)
FDA Class 1
·Microbiology
UNIVERSAL MOUTHPIECE, #750
FDA 510(k)
FDA Class 1
·Anesthesiology
SEE H10
FDA Adverse Event
Malfunction
·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code NBC·April 18, 2013
PUMP IN STYLE ADVANCED BREAST PUMP GO TOTE
FDA Adverse Event
Malfunction
·MEDELA, INC.·Product code HGX·June 2, 2014
PENUMBRA COIL 400
FDA Adverse Event
Malfunction
·PENUMBRA, INC.·Product code HCG·February 20, 2013
INTEGRATED APD SET W/CASSETTE3-PRONG
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·January 25, 2011
OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.
FDA Enforcement
Class II
·Ongoing·Exactech, Inc.·October 13, 2021